Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans

Not Applicable

Completed

• Conditions: Muscle Injury
• Interventions: Other: Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily); Other: Placebo (twice daily)

• Registration Number: NCT03754842
• Lead Sponsor: University of Aarhus

Brief Summary

Successful skeletal muscle regeneration depends on a functional pool of muscle stem cells, termed satellite cells (SC). SC are in a quiescent state throughout adulthood, but undergo multiple cycles of proliferation and self-renewal in response to muscle damage. During aging, there is a loss of SC quiescence, and SC more readily enter an ageing-state impairing their function.

Animal studies have revealed a common denominator for increasing SC function and activity, namely Sirtuin activation. Natural stimulators of Sirtuins includes Nicotinamide Riboside (NR) (a Nicotinamide adenine dinucleotide (NAD+) precursor) and the polyphenol Pterostilbene (PT). In this study, we aim to investigate if NR+PT supplementation will promote skeletal muscle regeneration after muscle damage in elderly humans by enhanced recruitment of SC.

Detailed Description

14 days after start of placebo or NR/PT (500/100 mg twice daily) supplementation a muscle damage will induced in the m. vastus lat. by electric stimulation combined with eccentric work in a dynamometer. Muscle biopsies will be collected at 2 hours, 2, 8 and 30 days post damage and placebo or NR/PT supplementation will continue for the whole study period (45 days).

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-27
• Study Start: 2019-02-12
• Status Verified: 2020-03
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Written signed consent
• Age: 55-80
• BMI: 20-28 (kg/(m2))
• Non-smoker

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Exclusion Criteria

• Endocrine disease, neurological or muscle disease
• Other severe disease
• High daily activity level (>30 min / day)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotinamide Riboside + Pterostilbene	Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)	-
Placebo	Placebo (twice daily)	-

Primary Outcome Measures

Name	Time	Method
Presence of Satellite Cells	Change from baseline up to 45 days	quantified by immunohistochemistry in muscle biopsies

Secondary Outcome Measures

Name	Time	Method
Presence of damaged muscle fibers	Change from baseline up to 45 days	determined by immunohistochemistry
Lipid accumulation in skeletal muscle tissue and liver	Change from baseline to 8 days	determined by magnetic resonance spectroscopy
Activation of Satellite cells	Change from baseline up to 45 days	determined by immunohistochemistry and FACS
Presence of macrophages	Change from baseline up to 45 days	determined by immunohistochemistry and FACS
Presence of Fibro/Adipogenic Progenitors	Change from baseline up to 45 days	quantified by FACS
Presence of muscle regenerative fibers	Change from baseline up to 45 days	determined by immunohistochemistry
Presence of autophagy in relation to muscle damage	Change from baseline up to 45 days	determined by Western blot and PCR
Blood glucose response in relation to muscle damage	Change from baseline to 8 days	determined by Continuous glucose monitoring
Body composition (lean body mass and fat body mass)	Change from baseline to 45 days	measured by Dual energy X-ray absorptiometry
Muscle strength	Change from baseline up to 45 days	determined from maximal voluntary contraction of the m. quadriceps femoris

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark